Alliance180 Program for Trauma

Recruiting at 1 trial location

Overseen By Keri J Heilman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Completed Alliance180 Program

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers. The study aims are: * Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers; * Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention. Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Alliance180 Program for Trauma treatment?

Research suggests that equine-assisted therapy, a component of the Alliance180 Program, can help improve the functioning of individuals with various health conditions, including trauma. Studies have shown that equine-assisted interventions may benefit traumatized youth and older adults by enhancing their well-being and psychosocial functioning. ^{1 2 3 4 5}

How is the Alliance180 Program for Trauma different from other treatments for trauma?

The Alliance180 Program is unique because it uses equine-assisted therapy, which involves interactions with horses to help improve emotional and social functioning. This approach is different from traditional talk therapies and is designed to address trauma by fostering trust, communication, and personal confidence through activities with horses. ^{4 6 7 8 9}

Research Team

Keri J Heilman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for US Veterans, First Responders, and Front Line Healthcare Workers who have experienced trauma or stress. Participants must be adults willing to report on their well-being and mental health before and after the Alliance180 Program at various intervals.

Inclusion Criteria

I am 18 years old or older.

Enrollment in an upcoming Alliance180 Program (limited to adults who currently or formerly serve as US Veterans, First Responders, and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)

Exclusion Criteria

Individuals who have previously completed the Alliance180 Program

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Research Session

Participants complete self-report measures of demographic information, perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life

1 day

1 visit (virtual)

Alliance180 Program

Participants attend the 3-day Alliance180 Program, including the Transformative Equine Experience

3 days

Post-intervention Research Sessions

Participants complete self-report measures of perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life at 1 week, 1 month, 3 months, and 6 months after the program

6 months

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Alliance180 Program

Trial Overview The Alliance180 Program's impact on physical and psychological well-being is being tested. The study will assess changes in feelings of safety, autonomic functioning, depression, anxiety, and trauma response over time after completing the program.

Participant Groups

Group I: Alliance180 Program Experimental Treatment 1 Intervention

Participants will attend the 3-day Alliance180 Program.

Alliance180 Program is already approved in United States for the following indications:

Approved in United States as Alliance180 Program for:

• Post-traumatic stress disorder (PTSD) prevention
• Suicide prevention
• Trauma response management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

ALLIANCE180, INC

Collaborator

Trials

1

Recruited

50+

Findings from Research

The pilot study involving 38 healthcare workers demonstrated that a four-hour equine-assisted resiliency psychotherapy intervention was safe and led to short-term improvements in psychological flexibility and positive affect, while reducing negative affect.

Despite these benefits, the intervention was underutilized, and there was no significant change in overall resiliency, indicating a need for future studies to enhance participation and explore the effectiveness of such interventions more rigorously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A replication study of a psychotherapy incorporating horses resiliency intervention for healthcare workers. Marchand, WR., Sullivan-Sakaeda, L., Lackner, R., et al.[2023]

Equine-Assisted Therapy (EAT) has been shown to significantly improve exercise tolerance and quality of life in individuals with various health conditions, based on a systematic review of 23 randomized clinical trials.

EAT also positively affects mobility and interpersonal interactions, indicating its potential as a beneficial therapeutic intervention for people with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted therapy on the functionality of individuals with disabilities: systematic review and meta-analysis. Prieto, A., Martins Almeida Ayupe, K., Nemetala Gomes, L., et al.[2022]

A new standardized assessment tool for equine-assisted therapy was developed based on the International Classification of Functioning, Disability and Health (ICF) framework, which includes a general module and three specialized submodules, tested with 116 participants across six therapy centers in Germany.

The tool demonstrated good to excellent reliability and supports a structured approach to measuring the effects of equine-assisted therapy, potentially enhancing its integration into the international healthcare system and enabling evidence-based outcome measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an ICF-based assessment tool for equine-assisted therapy: model structure and reliability. Stolz, I., Tillmann, V., Anneken, V., et al.[2023]

Equine Facilitated Psychotherapy (EFP) shows promise for helping traumatized youth, particularly those with complex trauma histories, as highlighted by the development of a new model called Equine Facilitated Therapy for Complex Trauma (EFT-CT).

The article presents three case studies that utilize both clinician observations and longitudinal psychosocial measures, suggesting that EFT-CT may effectively integrate EFP practices within an established trauma treatment framework, potentially improving outcomes for affected youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine Facilitated Therapy for Complex Trauma (EFT-CT). Naste, TM., Price, M., Karol, J., et al.[2023]

Equine-assisted interventions (EAI) have shown positive effects on various health aspects in older adults, including improvements in physical balance, gait, and muscular strength, as well as enhancements in quality of life and physiological measures like hormonal activity.

Out of 13 studies reviewed, EAI demonstrated significant benefits across physical, psychological, and physiological health domains, suggesting it could be a valuable non-pharmacological treatment option for promoting well-being in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted interventions on older adults' health: A systematic review. Badin, L., Alibran, É., Pothier, K., et al.[2022]

A study involving 63 veterans with PTSD showed that an 8-session group Equine-Assisted Therapy (EAT-PTSD) resulted in significant reductions in PTSD and depression symptoms, with improvements lasting up to 3 months after treatment.

The therapy was well-accepted, with only 8% of participants withdrawing, indicating its feasibility and potential as a safe intervention for veterans seeking help for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. Fisher, PW., Lazarov, A., Lowell, A., et al.[2021]

Equine-assisted psychotherapy (EAP) significantly improved the mental health of children, as shown by a rise in the Children's Global Assessment of Functioning (GAF) scores from a mean of 54.1 to 61.7 after an average of 19 sessions, indicating effective intervention for behavioral and mental health issues.

The study found that younger children and those with a history of physical abuse and neglect experienced the greatest improvements, suggesting that EAP may be particularly beneficial for these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-assisted psychotherapy: a mental health promotion/intervention modality for children who have experienced intra-family violence. Schultz, PN., Remick-Barlow, GA., Robbins, L.[2007]

A 6-week equine-assisted psychotherapy (EAP) program for veterans with PTSD showed similar improvements in PTSD symptoms and resilience compared to standard therapy, suggesting it may be an effective alternative treatment.

While both groups experienced significant reductions in PTSD symptoms and increases in resilience, there was no statistically significant difference in the outcomes between the EAP and control groups, indicating that EAP could be as beneficial as traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. Burton, LE., Qeadan, F., Burge, MR.[2020]

The newly developed eight-session equine-assisted therapy (EAT) protocol for PTSD was found to be safe and well-accepted by military veterans, with no reported adverse events and high treatment completion rates.

Preliminary results indicated significant reductions in PTSD and depressive symptoms post-treatment, with medium to large effect sizes, although these benefits did not persist at the 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Arnon, S., Fisher, PW., Pickover, A., et al.[2021]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

A replication study of a psychotherapy incorporating horses resiliency intervention for healthcare workers. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted therapy on the functionality of individuals with disabilities: systematic review and meta-analysis. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Development of an ICF-based assessment tool for equine-assisted therapy: model structure and reliability. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Equine Facilitated Therapy for Complex Trauma (EFT-CT). [2023]

5. China pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted interventions on older adults' health: A systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Equine-assisted psychotherapy: a mental health promotion/intervention modality for children who have experienced intra-family violence. [2007]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. [2021]